Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-06 @ 1:45 PM
Study NCT ID:
NCT03741192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-07-10
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care.\n\nDemographics will be obtained for both groups during this initial clinic visit. The treatment group will be prescribed the Brain Sentinel® SPEAC System for use in the home environment. Study Participants in the standard of care group will be given standard care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-11-12', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Impact Form Questionnaire', 'timeFrame': 'Up to 5 months', 'description': "The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan."}], 'secondaryOutcomes': [{'measure': 'Personal Impact of Epilepsy Scale (PIES) Survey', 'timeFrame': '1 year', 'description': 'The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.'}, {'measure': 'VR-12 Survey', 'timeFrame': '1 year', 'description': 'This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).'}, {'measure': 'Personal Impact of Epilepsy Scale (PIES) Survey', 'timeFrame': '5 years', 'description': 'The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.'}, {'measure': 'VR-12 Survey', 'timeFrame': '5 years', 'description': 'This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).'}, {'measure': 'VA Administrative Data', 'timeFrame': '1 year', 'description': 'Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.'}, {'measure': 'VA Administrative Data', 'timeFrame': '5 years', 'description': 'VA administrative data will be used to evaluate health outcomes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Epilepsy Intractable']}, 'descriptionModule': {'briefSummary': 'This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.\n2. Subjects suspected of experiencing one or more spells per month.\n3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).\n4. Male or Female between the ages 22 to 99.\n5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.\n6. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.\n7. Subject or Primary Caregiver must be competent to follow all study procedures.\n8. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period (up to five months), for a minimum of 30 hours/ week.\n\nExclusion Criteria:\n\n1. The subject cannot be pregnant, or nursing.\n2. The subject cannot be sensitive or allergic to adhesives or tapes.\n3. The subject may not be enrolled in another Clinical Trial.\n4. The subject is homeless or in a home without a power supply.'}, 'identificationModule': {'nctId': 'NCT03741192', 'briefTitle': "Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs", 'organization': {'class': 'OTHER', 'fullName': 'Brain Sentinel'}, 'officialTitle': "Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs", 'orgStudyIdInfo': {'id': 'CPT-04-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'SPEAC System', 'interventionNames': ['Device: SPEAC System']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care'}], 'interventions': [{'name': 'SPEAC System', 'type': 'DEVICE', 'otherNames': ['Brain Sentinel Monitoring and Alerting System'], 'description': 'Surface Electromyography (sEMG) based seizure monitoring and alerting system', 'armGroupLabels': ['Treatment Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brain Sentinel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}